Ankle Fracture Treatment in the Elderly

September 29, 2017 updated by: University of Florida

Ankle Fracture Treatment in the Elderly, at Risk Population

The purpose of this study is to track surgical outcomes and post-operative course in patients 55 years of age or older treated for ankle fractures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study seeks to describe and track surgical outcomes associated with the use of a minimally invasive surgical technique used to treat ankle fractures in at-risk patients 55 years of age or older

Study Type

Observational

Enrollment (Actual)

118

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32607
        • UF&Shands Orthopaedics and Sports Medicine Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

At-risk population, at least 55 years of age at time of surgery receiving treatment for ankle fractures.

Description

Inclusion Criteria:

  • at least 55 years of age at time of surgery
  • receiving treatment for ankle fractures

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ankle Fracture
Patients aged 55 years at time of surgery undergoing treatment for ankle fractures.
Other: Fracture union
Retrospective records review post-operatively until fracture resolved.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Status of Fracture Union
Time Frame: Post-operatively until documentation of fracture healing, assessed up to seven months following surgery.
Retrospective records review tracking ankle fractures post-operatively until fracture heals.
Post-operatively until documentation of fracture healing, assessed up to seven months following surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative Complications
Time Frame: Post-operatively until documentation that complications resolved, assessed up to seven months following surgery.
Retrospective record review tracking complications post-operatively until resolved.
Post-operatively until documentation that complications resolved, assessed up to seven months following surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Kalia K Sadasivan, M.D., University of Florida Department of Orthopaedics and Rehabilitation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2011

Primary Completion (Actual)

April 3, 2011

Study Completion (Actual)

April 3, 2011

Study Registration Dates

First Submitted

September 26, 2011

First Submitted That Met QC Criteria

September 28, 2011

First Posted (Estimate)

September 30, 2011

Study Record Updates

Last Update Posted (Actual)

October 3, 2017

Last Update Submitted That Met QC Criteria

September 29, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 146-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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